Blood control for a catheter insertion device

ABSTRACT

A fluid control component configured for controlling fluid flow through the hub of a catheter assembly during and after placement into the patient is disclosed. In one embodiment, the fluid control component comprises a body disposed within a cavity of the hub, the body being movable between a first position and a second position, wherein the body does not pierce a valve disposed in the hub when in the first position and wherein the body pierces the valve when in the second position. The body includes a conduit to enable fluid flow through an internal portion of the body when the body is in the second position, and a plurality of longitudinally extending ribs disposed on an exterior surface of the body. The ribs provide at least one fluid flow channel between the valve and an external portion of the body when the body is in the second position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.15/702,537, filed Sep. 12, 2017, now U.S. Pat. No. 10,493,262, whichclaims the benefit of U.S. Provisional Patent Application No.62/393,531, filed Sep. 12, 2016, and titled “BLOOD CONTROL FOR ACATHETER INSERTION DEVICE,” each of which is incorporated herein byreference in its entirety.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toa tool for assisting with the placement into a patient of a catheter orother tubular medical device. In particular, a fluid control componentconfigured for controlling fluid flow through the hub of the catheterassembly during and after placement into the patient is disclosed.

In one embodiment, the fluid control component comprises a body disposedwithin a cavity of the hub, the body being movable between a firstposition and a second position, wherein the body does not pierce a valvedisposed in the hub when in the first position and wherein the bodypierces the valve when in the second position. The body includes aconduit to enable fluid flow through an internal portion of the bodywhen the body is in the second position, and a plurality oflongitudinally extending ribs disposed on an exterior surface of thebody. The ribs provide at least one fluid flow channel between the valveand an external portion of the body when the body is in the secondposition.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A and 1B are perspective views of a catheter insertion deviceaccording to one embodiment;

FIG. 2 is an exploded view of the catheter insertion device of FIGS. 1Aand 1B;

FIG. 3 is a cross-sectional side view of a catheter according to oneembodiment;

FIG. 4 is a perspective view of a blood control component of thecatheter of FIG. 3 ;

FIGS. 5A and 5B show various views of the blood control component ofFIG. 4 ;

FIGS. 6A-6C show various views of a blood control component for acatheter according to one embodiment;

FIGS. 7A-7C show various views of use of the catheter and blood controlcatheter of FIGS. 6A-6C;

FIGS. 8A-8F show various views of a needle hub of the catheter insertiondevice of FIGS. 1A and 1B;

FIG. 9 is a cross sectional view of a flash indicator of the catheterinsertion device of FIGS. 1A and 1B;

FIG. 10 is a perspective view of a valve of the catheter insertiondevice of FIGS. 1A and 1B; and

FIG. 11 is an isolation view showing the blood control componentpiercing the valve of the catheter insertion device of FIGS. 1A and 1B.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present invention are generally directed to a toolfor assisting with the placement into a patient of a catheter or othertubular medical device. For example, catheters of various lengths aretypically placed into a body of a patient so as to establish access tothe patient's vasculature and enable the infusion of medicaments oraspiration of body fluids. The catheter insertion tool to be describedherein facilitates such catheter placement. Note that, while thediscussion below focuses on the placement of catheters of a particulartype and relatively short length, catheters of a variety of types,sizes, and lengths can be inserted via the present device, includingperipheral IVs, intermediate or extended-dwell catheters, PICCs, centralvenous catheters, etc. In one embodiment, catheters having a lengthbetween about 1.25 inch and about 2.25 inches can be placed, though manyother lengths are also possible.

FIGS. 1A-2 depict various details regarding a catheter insertion tool(“insertion tool” or “insertion device”), generally depicted at 10,according to one embodiment. As shown, the insertion tool 10 includes ahousing 12 that may itself include a proximal housing portion 12A and adistal housing portion 12B. The housing 12 further includes an opendistal end, and can include a flat bottom to enable the insertion device10 to lie flat on a surface without tipping. In another embodiment, thehousing is integrally formed. In yet another embodiment, a top housingportion and a bottom housing portion can be employed, or more than twoportions can be used. In the present embodiment, the housing composed ofa thermoplastic such as polycarbonate and is translucent, though otherconfigurations are contemplated. The housing 12 defines grip surfaces 13on either side of the housing, as seen in FIGS. 1A and 1B, to enablegrasping of the insertion device 10 by the user.

A needle hub 14 supporting a hollow needle 16 (which together form partof a needle assembly, in one embodiment) is included with the housing12. In the present embodiment, the needle hub 14 is secured within thehousing 12 within a cavity 13 defined by the housing, but in anotherembodiment it can be integrally formed with the housing.

As will be described in detail further below, the needle hub 14 includesa slot for receiving a portion of the needle 16 and a quantity ofadhesive, such as liquid or UV-cure adhesive for example, in order tofix the needle in place in the needle hub. The needle 16 extendsdistally from the needle hub 14 so as to extend past the distal end ofthe distal housing portion 12B and terminates at a distal end 16Bthereof. A notch 18 is defined through the wall of the needle 16proximate the distal end thereof. The notch 18 enables flashback ofblood to exit the lumen defined by the hollow needle 16 once access tothe patient's vasculature is achieved during catheter insertionprocedures. Thus, blood exiting the notch 18 can be viewed by aclinician to confirm proper needle placement in the vasculature, as willbe explained further below.

A catheter 42 including a catheter tube 44 is removably disposed on theportion of the needle 16 residing external to the housing 12 such thatthe needle occupies a lumen of the catheter defined by a catheter tube.The catheter tube 44 extends distally from a hub 46 of the catheter 42,which hub is initially disposed adjacent the open distal end of thedistal housing portion 12B, as shown in FIGS. 1A and 1B.

The insertion device 10 further includes a guidewire advancementassembly 20 for advancing a guidewire 22 through the needle 16 and intothe vasculature of the patient once vessel access by the needle has beenachieved. The guidewire 22 (FIGS. 1A-2 ) is pre-disposed within thelumen of the needle 16. The guidewire advancement assembly 20 includes aguidewire lever 24 that selectively advances the guidewire 22 in adistal direction during use of the insertion device 10 such that thedistal portion of the guidewire extends beyond the distal end 16B of theneedle 16. In the present embodiment, a finger pad 28 of the guidewirelever 24 is slidably disposed on the housing 12 via a slot 32 to enablea thumb and/or finger(s) of the user to selectively advance theguidewire 22 distally past the distal end 16B of the needle 16. Ofcourse, other engagement schemes to translate user input to guidewiremovement could also be employed. In one embodiment, the guidewire 22 caninclude a guidewire support tube to provide additional stiffness to theguidewire and facilitate its distal advancement described above. In yetanother embodiment, a proximal end of the guidewire can be attached atan anchor point on an interior portion of the housing 12 (or other fixedportion of the insertion device 10) and looped about a proximal portionof the guidewire lever 24 in a roughly U-shaped configuration such thatthe distal end of the guidewire extends two units of distance distallypast the distal end 16B of the needle 16 for every one unit of distanceof movement of the finger pad 28. These and other modifications aretherefore contemplated.

The majority length of the guidewire in one embodiment includes a metalalloy of nickel and titanium commonly referred to as nitinol, thoughother suitable guidewire materials can also be employed.

FIGS. 1A and 1B show that the catheter 42 is removably attached to theinsertion device 10 such that the catheter tube 44 thereof is disposedover the portion of the needle 16 that extends distal to the housing 12such that the catheter resides external to the insertion device housing.The catheter 42 in the present embodiment is kept in place against theopen distal end of the housing via a friction fit with one or morefeatures disposed on the housing distal end. A tab 48 is included on thecatheter hub 46 for assisting with manual distal extension of thecatheter 42 by a user during deployment thereof.

Note that in one embodiment the outer diameters (and/or other areas) ofthe needle 16 and the catheter tube 44 are lubricated with silicone orother suitable lubricant to enhance sliding of the catheter tube withrespect to the needle and for aiding in the insertion of the catheterinto the body of the patient.

The insertion device 10 includes a retraction system configured toselectively retract the needle 16 into the housing 12. In detail, aspring element, such as a coil spring 50, is disposed between a distalend of the inner cavity 13 of the housing 12 and a ridge 144 disposed ata proximal end of the needle hub 14. The spring 50 is disposed about theneedle hub 14, and the needle hub is proximally slidable within thecavity of the housing 12. The needle hub 14 is kept in a distal positionwithin the cavity of the housing 12, with the spring maintained in acompressed configuration, by a retraction button 52 disposed near thedistal end of the housing 12. Manual depression of the retraction button52 releases engagement of the retraction button with the needle hub 14,which in turn enables the spring 50 to expand, causing the needle hub tomove proximally within the cavity of the housing 12. This in turnretracts the needle 16 so that the distal end 16B thereof is retractedinto the housing 12 and protected from inadvertent contact by a user.Note that other needle safety configurations can also be employed.

Use of the insertion device 10 in placing the catheter 42 in thevasculature of a patient is described here. A user grasping theinsertion device 10 first guides the distal portion of the needle 16through the skin at a suitable insertion site and accesses asubcutaneous vessel. After needle access to the vessel is confirmed, theguidewire advancement assembly 20 is actuated, wherein the finger pad 28(disposed in the slot 32 defined in the housing 12) is advanced by thefinger of the user to distally advance the guidewire 22 (FIG. 3A),initially disposed within the hollow needle 16. Note that the guidewire22 is distally advanced by the guidewire lever 24, which is operablyattached to the slidable finger pad 28.

Distal advancement of the guidewire 22 continues until the finger pad 28has been distally slid a predetermined distance, resulting in apredetermined length of the guidewire 22 extending past the distal endof the needle 16, as shown in FIGS. 1A and 1B. This places the distalportion of the guidewire 22 within the vessel.

Once the guidewire lever 24 has been fully distally extended via slidingof the finger pad 28, which in turn has extended the guidewire 22 pastthe distal end 16B of the needle 16, manual distal advancement of thecatheter 42 is performed, using the tab 48 of the catheter hub 46, whichcauses the catheter tube 44 to slide over distal portions of the needle16 and guidewire 22 and into the patient's vasculature via the insertionsite. In light of this, it is appreciated that the finger pad 28 acts asa first member used to advance the guidewire 22, whereas manualadvancement is employed to advance the catheter 42, in the presentembodiment. In another embodiment, it is appreciated that the finger pad28 can be employed to also distally deploy the catheter 42 at least apartial distance into the vessel.

The catheter 42 is distally advanced until it is suitably disposedwithin the vessel of the patient. The retraction button 52 on thehousing 12 is then manually depressed by the user, which causes thespring 50 to decompress and retract the needle hub 14, which in turncauses the distal end 16B of the needle 16 to be retracted within thehousing 12 and preventing its re-emergence, thus protecting the userfrom accidental needle sticks. Thus, this serves as one example of aneedle safety component, according to the present embodiment; others arepossible. The catheter 42 is physically separated from the housing 12 atthis time. Now in place within the patient, the catheter 42 can beprepared for use and dressed, per standard procedures. Then insertiondevice 10 can be discarded.

In additional detail, FIG. 2 shows a continuous blood flash indicator 80that can be used with the insertion device 10 according to oneembodiment. The flash indicator 80 is employed to indicate the presenceof blood in the lumen of the needle 16 during use of the device 10, thusassuring that proper access has been made by the needle into a vein orother desired blood-carrying vessel. As shown in FIG. 9 , the flashindicator 80 includes a translucent chamber 82 that is generallycylindrical in shape, sealed at either end, and disposed about a portionof the needle 16 such that the needle protrudes out from either sealedend. In the present embodiment the chamber 82 of the flash indicator 80is disposed in the slot 142 (FIGS. 8A-8F) of the needle hub 14 withinthe housing 12, though other locations along the needle are alsopossible.

Two notches—a first notch 83 and a second notch 84—are defined in theneedle 16 so as to provide fluid communication between the lumen of theneedle and the interior of the flash indicator chamber. The notches 83,84 replace the notch 18 (FIG. 2 ) in one embodiment, and are included inaddition to the notch 18, in another embodiment. It is appreciated that,in one embodiment, blood passage through the notch 18 serves as aninitial indicator that the distal end 16B of the needle has entered thevein, while the embodiment shown here serves as an additional indicatorto verify that the needle distal end remains in the vein after initialaccess. Further detail regarding the flash indicator 80 can be found inU.S. Publication No. 2016/0331938, published Nov. 17, 2016, and entitled“Catheter Placement Device Including an Extensible Needle SafetyComponent,” which is incorporated herein by reference in its entirety.

In the present embodiment, the guidewire 22 passes through the lumen ofthe needle 16 so as to extend through the flash indicator 80. The firstnotch 83 is disposed distal to the second notch 84 toward the distal endof the chamber 82.

When vessel access is achieved by the distal end 16B of the needle 16,blood travels proximally up the lumen of the needle, between the innersurface of the needle and the outer surface of the guidewire 22,disposed in the needle lumen (FIG. 9 ). Upon reaching the relativelymore distal first notch 83 defined in the needle 16, a portion of theblood will pass through the first notch and enter the chamber 82. As theblood fills the translucent chamber 82, a user can observe the chamberthrough the translucent housing 12 of the insertion device 10 and viewthe blood therein, thus confirming that the vessel access has beenachieved. In another embodiment, the housing 12 can be configured suchthat direct viewing of the chamber 82 is possible, e.g., with nointervening structure interposed between the chamber and the user.

The second notch 84 is employed to provide an exit point for air in thechamber 82 to equalize air pressure and enable the blood to continueentering the chamber via the first notch 83. It is noted that thespacing between the inner surface of the needle 16 and the outer surfaceof the guidewire 22 along section 85 is such that air but not blood canpass therebetween, thus enabling air pressure equalization in thechamber without blood passage through the second notch 84. In this way,the flash indicator 80 is a continuous indicator, enabling a continuousflow of blood into the chamber 82 while the needle distal end 16B isdisposed within the blood-carrying vessel.

Note that the catheter insertion device 10 can include more than oneflash indicator. In one embodiment and as mentioned above, for instance,the blood flash indicator 80 can be included, along with another flashindicator, such as the notch 18, which enables blood present in thelumen of the needle 16 to proceed proximally up the space between theouter surface of the needle and the inner surface of the catheter 42.

FIG. 3 depicts various details of a blood control component 100 includedwith the catheter 42, in accordance with one embodiment. As shown, theblood component 100 is slidably disposed within a cavity 46A of thecatheter hub 46 and is configured to selectively enable fluid flowthrough the catheter 42 in concert with a valve 102, also disposedwithin the catheter hub cavity. The valve 102 in the present embodimentis a tricuspid valve including three leaflets 102A defined by aplurality of slits 103 as seen in FIG. 10 , though other valve types mayalso be employed.

FIGS. 4-5B depict various details of the blood control component 100,including an elongate body 104 extending between a proximal end 104A anda distal end 104B and defining a central conduit 106 through whichfluids can flow. A plurality of ribs 110 is disposed on an outer surfaceof the body 104 such that the ribs longitudinally extend from proximallypast the proximal end 104A of the body to the distal end 104B thereof.Each rib 110 radially extends from the body 104 to define a contouredprofile along the longitudinal length thereof. The body 104 and ribs 110contribute to generally define a conical shape to the blood controlcomponent 100. Deviations from the conical shape are also possible inother embodiments.

Each rib 110 further defines a notch 112 intermediately positioned alongthe longitudinal length of the rib, as well as a protrusion 114 at theproximal end of the rib. As seen in FIG. 3 , the notch 112 of each rib110 receives a portion of an annular ridge 120 defined on an innersurface of the catheter hub cavity 46A to keep the blood controlcomponent 100 in place within the cavity before actuation.Correspondingly, the protrusions 114 of each rib 110 engage with theannular ridge 120 when the blood control component 100 is actuated so asto prevent further distal movement thereof past its intended length oftravel. The body 104 defines a channel 126 between adjacent ribs 110,thus providing four fluid flow channels in the illustrated embodiment.Note that in one embodiment one or more ribs 110 can be offset along thelongitudinal length thereof such that a proximal portion of the ribincluding the protrusion 114 is not longitudinally aligned with (as inFIGS. 5A and 5B), but rather circumferentially offset from, a moredistal portion of the rib.

FIGS. 6A-6C depict details of the blood control component 100 accordingto another embodiment, wherein the body 104 defines a plurality ofchannels 126 disposed about the conduit 106. An intermediate, annularshoulder 128 is also defined by the body 104.

FIGS. 7A-7C depict various stages of operation of the blood controlcomponent 100 of FIGS. 6A-6C, though the principles described here alsoapply to the embodiment shown in FIGS. 4-5B as well. In particular,FIGS. 7A and 7B show the blood control component 100 in a relativelyproximal position, also referred to herein as an un-actuated state,wherein the annular ridge 120 is received within the notches 112 (belowthe shoulders 128) of each rib 110 of the blood control component. Inthis position, the distal end 104B of the body 104 does not protrudethrough the valve 102 that is positioned distal to the blood controlcomponent and thus no fluid is able to pass through the catheter 42, asdesired. The valve 102 in the closed position thus prevents bloodleakage through the catheter 42, such as when the catheter has beenplaced within the patient but no external connection has been made tothe catheter hub 46.

In contrast, FIG. 7C shows the blood control component 100 in arelatively distal position, also referred to herein as an actuatedstate, wherein the blood control component has been distally advanced(such as by insertion of a male luer connector into the catheter hub 46)such that the distal end 104B thereof has penetrated through theleaflets 102A of the valve 102, thus providing a fluid path through thevalve via the conduit 106 of the blood control component. Further distaladvancement of the blood control component 100 is prevented byengagement of the protrusions 114 against the annular ridge 120. Asmentioned, the distal movement of the blood control component 100 iscaused by the insertion into the catheter hub cavity 46A by a luerconnector or other apparatus that can be operably connected to thecatheter hub 46.

In accordance with the present embodiment, the blood control component100 is configured to eliminate an entrapment zone between the bloodcontrol component and the valve 102 after the blood control componenthas pierced the valve in its actuated state. Specifically, and withrespect to the embodiment shown in FIGS. 4-5B, the ribs 110 causeadditional deformation of the leaflets 102A of the valve 102 when theblood control component pierces the valve, as seen in FIG. 11 . This inturn prevents partial sealing of the leaflets 102A to the exteriorsurface of the blood control component body 104, thus providing spacingtherebetween and additional fluid flow paths via the channels 126between the exterior surface of the blood control component body 104 andthe valve leaflets. Thus, fluid is able to flow through the catheter hubcavity 46A not only internal to the blood control component body 104 viathe conduit 106 but also external to the blood control component bodyvia the channels 126, which are made patent by the interaction of theribs 110 with the valve leaflets 104A. This fluid flow external to theblood control component 100 assists in moving fluid through the entiretyof the hub cavity 46A, thus desirably preventing fluid flow stagnationin the region between the blood control component 100 and the valve 102.

Note that in the present embodiment an outer termination point of eachslit 103 that form the leaflets 102A defines a staggered terminationpoint, as seen in FIG. 11 . Note also that the ribs described herein arebut one example of one or more extended surfaces that can be includedwith the blood control component to enable additional fluid flowchannels to be defined on an outer surface of the blood controlcomponent to enable fluid flow about the exterior of the blood controlcomponent when the blood control component pierces the valve. Examplesof other extended surfaces include bumps, annular surfaces, fins, etc.These and other embodiments are therefore contemplated.

The blood control component 100 of FIGS. 6A-6C operates similarly tothat described immediately above in connection with FIGS. 4-5B, whereinthe channels 126 provide fluid flow in addition to the conduit 106 so asto prevent fluid flow stagnation between the blood control component 100and the valve 102.

FIGS. 8A-8F depict various details regarding the aforementioned needlehub 14 of the insertion device 10, which includes an elongate body 140extending between a proximal end 140A and a distal end 140B. A slot 142extends longitudinally along the length of the body 140 and is sized forreceiving a portion of the length of the needle 16 therein. Asmentioned, the ridge 144 is included on the proximal end 140A of theneedle hub and provides a surface against which the spring 50 can act toretract the needle hub and attached needle 16 into the cavity of thehousing 12. The slot 142 defines a volume 146 within which theabove-described flash indicator 80 can be received.

Note that the slot 142 is configured so that differing sizes of needlecan be received and affixed therein. To that end, the slot 142 includesthree shoulders 148 to support the needle 16 within the slot 142. Notethat the proximal edge of each of the shoulders 148 is relatively abruptin shape so as to prevent spillage of a liquid epoxy adhesive that isplaced in the slot 142 proximate the shoulders to secure the needle 16within the slot.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A method of making a catheter assembly,comprising: forming a catheter, comprising: a catheter tube; and acatheter hub coupled to a proximal end of the catheter tube, thecatheter hub including a valve and an annular ridge defined proximal ofthe valve; forming a fluid control component, comprising: a conduitfluidly connecting a proximal opening in a proximal end of the fluidcontrol component to a distal opening in a distal end of the fluidcontrol component; and a plurality of longitudinally extending ribsdisposed on an exterior surface of the fluid control component, each ofthe ribs extending from the proximal end to the distal end, each of theplurality of longitudinally extending ribs comprising: a notch at anintermediate portion between the proximal end and the distal end, thenotch engaging the annular ridge in a first position; and a protrusionat the proximal end configured to engage the annular ridge in a secondposition; and positioning the fluid control component into the catheterhub so that the fluid control component is movable between: the firstposition with the distal end positioned proximal of the valve; and thesecond position with the distal end positioned distal to the valve. 2.The method of making according to claim 1, wherein the valve includes atricuspid valve including three slits.
 3. The method of making accordingto claim 2, wherein an outer termination point of each slit is astaggered termination point.
 4. The method of making according to claim1, wherein each of the ribs includes a shoulder at an intermediate pointbetween the proximal end and the distal end of the fluid controlcomponent.
 5. The method of making according to claim 1, wherein thefluid control component has a generally conical shape.
 6. The method ofmaking according to claim 1, wherein the plurality of longitudinallyextending ribs comprise four equally spaced longitudinally extendingribs around a circumference of the fluid control component.
 7. Themethod of making according to claim 1, wherein each of the plurality oflongitudinally extending ribs extend proximal of the proximal opening.8. The method of making according to claim 1, wherein the fluid controlcomponent further comprises a fluid flow channel between each of theplurality of longitudinally extending ribs.